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FDA 510(k)

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

K-Number: K201832 · 2021-09-17

ApplicantOlympus Medical Systems Corp.
Decision Date2021-09-17
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2021-09-17 under 510(k) number K201832. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5?

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 is a medical device that received FDA 510(k) clearance on 2021-09-17. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K201832.

When did Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 receive FDA 510(k) clearance?

Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 received FDA 510(k) clearance on 2021-09-17, under 510(k) number K201832.

Who is the listed applicant for Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5?

The FDA 510(k) record lists Olympus Medical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5?

The FDA product code for Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 is HET.

Other records listing Olympus Medical Systems Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)K261260HD Camera Head OLYMPUS CH-S200-08-LBK260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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Related Devices (Code: HET)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K210104SurroundScope System270surgical , Ltd.K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))Schoelly Fiberoptic GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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